BONE SCREW 6.5MM DIA X 25MM LONG
Received Jul 15, 2026 · Event occurred Sep 23, 2022
Report 1038671-2026-00900 · MDR key 25830777
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Manufacturer
Exactech, Inc.Catalog number
120-65-25
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
56 YR · Female
- Bone Fracture(s)
- Pain
- Aseptic loosening
Narrative
Description of Event or Problem
REPORT #2 OF 2 FOR THIS EVENT. AS REPORTED VIA LEGAL DOCUMENTATION A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, NINE (9) YEARS, SEVEN (7) MONTHS LATER, THE PATIENT EXPERIENCED PAIN AND SIT TO STAND MOBILITY DIFFICULTY, PINCHING AND ACHING. IT WAS REPORTED THE PATIENT'S RECOVERY WAS UNEVENTFUL HAVING COMPLETED A PHYSICAL THERAPY PROGRAM. AS A RESULT, THE PATIENT UNDERWENT A HIP REVISION PROCEDURE DUE TO ASEPTIC LOOSENING AND POLYETHYLENE LINER PROSTHESIS WEAR. INTRAOPERATIVELY, THE SURGEON NOTED THAT THE LINER WAS NEARLY COMPLETELY WORN THROUGH WITH THE FRACTURE LINE IN IT AND THE SCREW WAS FOUND TO BE LOOSE AND PROMINENT. ADDITIONALLY, INTRAOPERATIVELY THE PATIENT REQUIRED PROPHYLACTIC CABLE FIXATION OF THE PROXIMAL FEMUR AND OPEN REDUCTION AND INTERNAL FIXATION OF THE GREATER TROCHANTER WITH PLATE AND CABLE DUE TO FRACTURE. THE PATIENT WAS REVISED TO ANOTHER MANUFACTURER'S CONSTRUCT. THE PATIENT WAS PLACED IN AN ABDUCTION PILLOW AND THEN TRANSFERRED TO THE HOSPITAL BED AND TAKEN TO THE PATIENT AFTER CARE UNIT IN STABLE CONDITION.